(30 days)
Not Found
No
The summary explicitly states that there are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the device, and the only change is a labeling update. There is no mention of AI or ML in the description of the system's components or function.
No
The device is described as an Endoscopic Instrument Control System intended to assist in the accurate control of surgical instruments for various procedures, not to provide therapy itself.
No
The device description indicates that the da Vinci System is intended for surgical procedures, assisting in the control of endoscopic instruments for tasks like grasping, cutting, and suturing, rather than diagnosing conditions.
No
The device description clearly outlines physical hardware components including a Surgeon Console, Patient Side Cart, Master Tool Manipulators, Patient Side Manipulators, Endoscope Camera Manipulator, stereo endoscope, endoscopic camera, light source, and light guides. This is not a software-only device.
Based on the provided text, the Intuitive Surgical® da Vinci® Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for assisting in the accurate control of endoscopic instruments for surgical procedures (grasping, cutting, suturing, etc.) on tissue within the body.
- Device Description: The description details a surgical system with a surgeon console, patient side cart, manipulators, and an endoscopic vision system. These components are designed for performing surgical interventions, not for examining specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The da Vinci System's function is entirely focused on facilitating surgical procedures.
N/A
Intended Use / Indications for Use
The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") is intended to assist in the accurate control of Intuitive Surgical" Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Product codes
NAY
Device Description
This special 510(k) is being submitted for a minor labeling change / clarification on the da Vinci® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System or the Guidant Flex 10 ablation probe and Microwave Ablation System. The only change is an updated indication statement and addendum user manual sheet for the da Vinci® Surgical System.
The da Vinci® Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237, K013946 / K041340
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
DEC 1 5 2004
Section II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K043153
| Date | December 7, 2004 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Mike Yramategui |
| Director, Regulatory Affairs | |
| Telephone: (408) 523 - 2145 | |
| Fax: (408) 523 - 1390 | |
| e-mail: mike.yramategui@intusurg.com | |
| Subject | |
| Device | Name: Intuitive Surgical® da Vinci® Surgical System and Endoscopic |
| Instruments | |
| Classification Name: System, Surgical, Computer Controlled Instrument | |
| (21 CFR 876.1500) | |
| Common Name: Endoscopic Instrument Control System, Endoscopic | |
| Instruments and Accessories | |
| Predicate | |
| Devices | Intuitive Surgical® da Vinci® Surgical System and Endoscopic |
| Instruments (legally marketed under K990144 / K002489 / K011002 / | |
| K013416 / K021036 / K022574 / K040237); Guidant Microwave | |
| Ablation System and Flex 10 Accessory (legally marketed under | |
| K013946 / K041340) | |
| Device | |
| Description | This special 510(k) is being submitted for a minor labeling change / |
| clarification on the da Vinci® Surgical System. There are no changes in | |
| the design, technology, materials, manufacturing, performance, | |
| specifications, and method of use for the da Vinci Surgical System or the | |
| Guidant Flex 10 ablation probe and Microwave Ablation System. The | |
| only change is an updated indication statement and addendum user | |
| manual sheet for the da Vinci® Surgical System. |
The da Vinci® Surgical System consists of two integrated sub-systems as
1
K043i53 2/3
follows:
Device Description (continued)
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
- The Intuitive Surgical® Endoscopic Instrument Control System is Intended Use intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation. electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
2
| Comparison to
Predicate
Device | There are no changes in the design, technology, materials,
manufacturing, performance, specifications, and method of use for the da
Vinci® Surgical System or the Guidant Flex 10 probe and Microwave
Ablation System. The only difference is an updated indication statement
that provides a clarification of tasks that can be performed with the da
Vinci Surgical System; and an addendum instruction sheet that provides
operational information for use of the da Vinci® Surgical System with the
Guidant Flex 10 Probe and Microwave Ablation System. The use of the
da Vinci Surgical System to deliver and place the Flex 10 probe is
equivalent to using conventional minimally invasive surgical
instruments. This change does not impact the operational characteristics
or change the intended use of either device. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The technological characteristics of the subject devices are the same as
for the predicate devices. |
| Performance
Data | Design analysis and comparison, as well as bench testing, has been
conducted to confirm that basic functional characteristics
are
substantially equivalent to the predicate devices cited, and that design
output meets the design input requirements. |
| Conclusion | Based upon the technical information, intended use, and performance
information provided in this pre-market notification, the da Vinci®
Surgical System described herein has been shown to be substantially
equivalent to current legally marketed predicate devices, and the results
of the design control process confirm that the design output meets the
design input requirements. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K043153
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System and Endoscopic Instruments
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: November 12, 2004 Received: November 15, 2004
Dear Mr. Yramategui:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K043153
Device Name: Intuitive Surgical" Endoscopic Instrument Control System and Endoscopic Instruments
Indications For Use:
The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") is intended to assist in the accurate control of Intuitive Surgical" Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
Page 1 of ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
510(k) Number K043153
Intuitive Surgical® da Vinci® Surgical System - Labeling Update / Clarification
SPECIAL 510(k) Section III, Page 1 of 1